MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568330999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On 3rd april, 2024 getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the small covers and tabs were missing from spring arm on the suspension side.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury in case of reoccurrence.

Manufacturer Narrative

The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: device evaluation anticipated, but not yet begun.Corrected h3b device not eval provide code: n/a.The unique identifier (udi) # information is not available as this medical device/model was marketed and/or discontinued in us before the udi requirement became mandatory.Getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the small covers and tabs were missing from spring arm on the suspension side.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury in case of reoccurrence.It was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.There is no information if the claimed device was used for patient treatment or diagnosis when the event took place.The possible root causes for covers missing are : non-conformity of the metal covers assembly.Degradation of the metal covers.Improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.The fall of plastic cover is due to an incorrect attachment of the dust cover or a detachment due to repeated collisions.The collision of the spring arms occurred during the handling of the device.The incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 19131727
• MDR Text Key: 341378928
• Report Number: 9710055-2024-00285
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568330999
• Device Catalogue Number: ARD568330999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 08/28/2024
• Supplement Dates FDA Received: 08/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1